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Virtual

Nov 03, 2021 8:45 AM - Nov 05, 2021 1:15 PM

(Central Europe Standard Time)

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

15th Anniversary

Session 6: Hot Topics in Pharmacovigilance

Session Chair(s)

Gemma  Jimenez Sese

Gemma Jimenez Sese

Senior Director, Deputy EU QPPV

AstraZeneca, Spain

Nicolas  Tsiakkas, MD

Nicolas Tsiakkas, MD

Scientific Director

NIKOLAS TSIAKKAS AND CO OE, Greece

This will be year seven for this very popular session. Typically, the session invites speakers who are leading discussions between industry trade associations and Regulatory Authorities on the key issues of the moment. The session provides insight into what are the hot topics under discussion, what progress has been made and what are the next steps. The session is of value to participants from both large and small companies alike as there is limited attendance possible at the public meetings with EMA so this is a fantastic opportunity to hear about these topics from individuals who are directly involved. The session consists of a series of several concise presentations that cover the key messages. This session is always a crowd pleaser!

Speaker(s)

Nuria  Semis-Costa, MSc

EMA GVP on RMM: Updates from a Regulator

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

Achint Kumar  Gupta, DrMed, MD

Signaling: EVDAS

Achint Kumar Gupta, DrMed, MD

Biogen Idec Ltd., United Kingdom

EU QPPV - Safety & Benefit-Riak Management

Judith  Weigel, MSc

EFPIA Updates: Feedback from Regulation Implementation Public Consultation

Judith Weigel, MSc

vfa - Association of Research-Based Pharmaceutical Companies, Germany

Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs,

Vicki  Edwards, RPh

ICH Updates

Vicki Edwards, RPh

Abbvie, United Kingdom

Vice President, Pharmacovigilance Excellence and International QPPV

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